UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043344
Receipt number R000049490
Scientific Title The effect of channa striata on tuberculosis outcome in children
Date of disclosure of the study information 2021/04/10
Last modified on 2021/02/16 22:52:35

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Basic information

Public title

Effect of channa striata on tuberculosis in children

Acronym

effect of channa striatus on nutritional status and cytokine level in tuberculosis children

Scientific Title

The effect of channa striata on tuberculosis outcome in children

Scientific Title:Acronym

effect channa striata on body mass index, Leptin level, albumin level, TNF-s, IFN-gamma in tuberculosis children

Region

Asia(except Japan)


Condition

Condition

clinical trial on supplementary drug for tuberculosis in children

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to analyze the effect of channa striata on tuberculosis in children

Basic objectives2

Others

Basic objectives -Others

to analyze the differences of cytokine level (TNF-a, IFN-gamma, IGF-b), leptin level, albumin level, and body mass index before and after suplementation.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

outcome of tuberculosis in children after 2 month suplementation of channa striata

Key secondary outcomes

improvement of albumin level
improvement of leptin level
improvement of cytokine level (TNF-a, IFN-gamma, IGF-beta)
improvement of body mass index


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

channa striata extract for 2 month
subject 2-5 years dose 2x250 mg
subject 6-14 years dose 2x500 mg

Interventions/Control_2

placebo with same form and eticket, with capsul or syrup glukosa base

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

2 years-old <=

Age-upper limit

14 years-old >=

Gender

Male and Female

Key inclusion criteria

clinical tuberculosis of lung in children 2-14 years old

Key exclusion criteria

severe tuberculosis form, include extrapulmonary TB, MDR TB
severe malnutrition
severe chronic disease
acute infectious disease on enrollement or admission
HIV positif

Target sample size

70


Research contact person

Name of lead principal investigator

1st name MOH
Middle name SYAROFIL
Last name ANAM

Organization

lecturer at diponegoro university faculty of medicine

Division name

pediatric respirology

Zip code

50244

Address

Bagian/KSM Ilmu Kesehatan Anak FK Undip/RSUP dr. Kariadi Semarang. Jl. dr Sutomo No.16. Gedung C1L2

TEL

081367428988

Email

msanam77@fk.undip.ac.id


Public contact

Name of contact person

1st name MOH
Middle name SYAROFIL
Last name ANAM

Organization

lecturer at diponegoro university faculty of medicine

Division name

pediatric respirology

Zip code

50244

Address

Bagian/KSM Ilmu Kesehatan Anak FK Undip/RSUP dr. Kariadi Semarang. Jl. dr Sutomo No.16. Gedung C1L2

TEL

0248414296

Homepage URL

https://www.undip.ac.id

Email

msanam77@fk.undip.ac.id


Sponsor or person

Institute

faculty of medicine diponegoro university

Institute

Department

Personal name



Funding Source

Organization

faculty of medicine diponegoro university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Indonesia


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Komisi Etik Penelitian Kesehatan FK Undip

Address

Jl. Dr. Sutomo No.18 Semarang

Tel

02476928010 (p.7820)

Email

komisietik@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

diponegoro university (semarang, indonesia)


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 10 Day


Related information

URL releasing protocol

on going

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2019 Year 07 Month 01 Day

Date of IRB

2019 Year 08 Month 21 Day

Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2021 Year 04 Month 01 Day

Date of closure to data entry

2021 Year 04 Month 10 Day

Date trial data considered complete

2021 Year 07 Month 01 Day

Date analysis concluded

2021 Year 08 Month 01 Day


Other

Other related information

On going research


Management information

Registered date

2021 Year 02 Month 16 Day

Last modified on

2021 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049490


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name